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Treatment of Depression Following Multiple Brain Tests
This study is currently recruiting participants.
Verified by New York State Psychiatric Institute, January 2008
Sponsored by: New York State Psychiatric Institute
Information provided by: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00296777
  Purpose

The main purpose of this study is to correlate brain testing with treatment outcome.


Condition Intervention Phase
Major Depression
Dysthymia
 Drug: Escitalopram
Drug: Bupropion
Drug: Imipramine
 Phase IV

MedlinePlus related topics: Depression
Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Bupropion hydrochloride Bupropion Imipramine Imipramine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study
Official Title: Medication Treatment Following Neuropsychologic, Dichotic and f-MRI Tests in Depressed Outpatients With Repeat f-MRI Following Treatment

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Hamilton Depression Scale (HAM-D) [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • EEG recordings [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • ERP recordings [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • f-MRI [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • STROOP test [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Simon Test [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Word Production [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Wisconsin Card Sort [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Block Design [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Letter Trials [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Chimeric Faces [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • NAR-T [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Digit Symbol Coding [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Syllables Test [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Tones Test [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Rhymed Words Test [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Beck Depression Inventory (BDI) [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Clinical Global Impression (CGI) [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Patient Global Impression (PGI) [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Inventory of Depressive Symptoms (IDS) [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Edinburgh Handedness Inventory [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Chapman Pleasure Scale [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Spielberger State/Trait Anxiety Inventory [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2004
Intervention Details:
    Drug: Escitalopram
    8 weeks: up to 40 mg/day
    Drug: Bupropion
    8 weeks: up to 450 mg/day (for patients without history of seizures or risk for developing seizures.
    Drug: Imipramine

    8 weeks: up to 300mg/day

    *if patient does not have contraindication.

Detailed Description:

40 medication-free Depressed Patients will receive a battery of neuropsychologic tests, standard dichotic listening tests, EEG, ERP and an f-MRI while performing a neuropsychologic test, the Simon. Once testing is completed, patients will be treated in an open treatment trial of SSRI. Non-responders will then receive Bupropion followed by Tricyclic Antidepressant if still depressed. While our main purpose is to correlate imaging testing with other measures of brain functioning, we also intend to see whether f-MRI findings demonstrate specific brain areas which differ between responders and non-responders. At the end of SSRI treatment, patients will have a second f-MRI scan to investigate any changes treatment and/or response may have caused.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV Major Depression or Dysthymia
  • Age 18-65
  • Physically healthy
  • Normal hearing
  • Drug-free (two weeks for most antidepressants, four weeks for Fluoxetine)

Exclusion Criteria:

  • Hearing deficit in one or both ears
  • Body metal (e.g., wire stitches, screws in bones, stainless steel hips)
  • History of Psychosis or Epilepsy
  • Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
  • Unstable medical problem
  • Insufficient English for neuropsychological and dichotic testing
  • Bipolar I
  • Need for wash-out from effective treatment in order to participate
  • Pregnant
  • High suicide risk
  • Currently taking (within 2 weeks; 4 weeks for Fluoxetine) antidepressants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296777

Contacts
Contact: Jonathan W. Stewart, M.D. (212) 543 5745 jws6@columbia.edu
Contact: Gerard E. Bruder, Ph.D. (212) 543 5468 bruderg@pi.cpmc.columbia.edu

Locations
United States, New York
Depression Evaluation Service - New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Jonathan W. Stewart, M.D.     212-543-5745     jws6@columbia.edu    
Contact: Gerard E. Bruder, Ph.D.     (212) 543 5468     bruderg@pi.cpmc.columbia.edu    
Principal Investigator: Jonathan W. Stewart, M.D.            
Sub-Investigator: Gerard E. Bruder, Ph.D.            
Sub-Investigator: Bradley Peterson, M.D.            
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Jonathan W. Stewart, MD. New York State Psychiatric Institute - Columbia University Department of Psychiatry
  More Information

Depression Evaluation Service - official website  This link exits the ClinicalTrials.gov site
New York State Psychiatric Institute - official website  This link exits the ClinicalTrials.gov site

Publications:
Taylor BP, Bruder GE, Stewart JW, McGrath PJ, Halperin J, Ehrlichman H, Quitkin FM. Psychomotor slowing as a predictor of fluoxetine nonresponse in depressed outpatients. Am J Psychiatry. 2006 Jan;163(1):73-8.
Bruder GE, Stewart JW, Voglmaier MM, Harrison WM, McGrath P, Tricamo E, Quitkin FM. Cerebral laterality and depression: relations of perceptual asymmetry to outcome of treatment with tricyclic antidepressants. Neuropsychopharmacology. 1990 Feb;3(1):1-10.
Bruder GE, Otto MW, McGrath PJ, Stewart JW, Fava M, Rosenbaum JF, Quitkin FM. Dichotic listening before and after fluoxetine treatment for major depression: relations of laterality to therapeutic response. Neuropsychopharmacology. 1996 Aug;15(2):171-9.
Stewart JW, Quitkin FM, McGrath PJ, Bruder GE. Do tricyclic responders have different brain laterality? J Abnorm Psychol. 1999 Nov;108(4):707-10.
Bruder GE, Stewart JW, Tenke CE, McGrath PJ, Leite P, Bhattacharya N, Quitkin FM. Electroencephalographic and perceptual asymmetry differences between responders and nonresponders to an SSRI antidepressant. Biol Psychiatry. 2001 Mar 1;49(5):416-25.
Bruder GE, Stewart JW, McGrath PJ, Deliyannides D, Quitkin FM. Dichotic listening tests of functional brain asymmetry predict response to fluoxetine in depressed women and men. Neuropsychopharmacology. 2004 Sep;29(9):1752-61.

Responsible Party: New York State Psychiatric Institute ( Jonathon W. Stewart )
Study ID Numbers: IRB4781
Study First Received: February 23, 2006
Last Updated: January 15, 2008
ClinicalTrials.gov Identifier: NCT00296777  
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Major Depression
Dysthymia
f-MRI
Escitalopram
Bupropion
 Imipramine
Neuropsychologic test
Dichotic listening
EEG
ERP

Study placed in the following topic categories:
Depression
Depressive Disorder, Major
Depressive Disorder
Citalopram
Serotonin
Behavioral Symptoms
Imipramine
 Dopamine
Mental Disorders
Bupropion
Mood Disorders
Dysthymic Disorder
Dexetimide

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Parasympatholytics
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Anti-Dyskinesia Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
 Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009



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